[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-receptor-positive-her-2-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-receptor-positive-her-2-negative-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,57,84,121,144,169,190,216,247,311],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100644477","early-phase-1-imaging-study-of-a-trop2-binder-in-metastatic-uc-hr-and-her2--breast-cancer-tnbc-and-nsclc-100644477",false,"NCT07671092","Imaging Study of a TROP2 Binder in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC","A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of a Trophoblast Cell Surface Antigen 2 (TROP2) Binder in Metastatic Urothelial Cancer (UC), Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Breast Cancer, Triple-Negative Breast Cancer (TNBC), and Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Are at least 18 years old at the time of signing the informed consent form (ICF)\n* Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC\n\nExclusion Criteria:\n\n* TROP2-targeting antibody-drug conjugates (ADCs) such as sacituzumab govitecan or datopotamab deruxtecan, should be discontinued at least 90 days prior to administration of RYZ211 and RYZ212\n* For Women of Childbearing Potential: Are pregnant or breastfeeding\n\nNote: Additional criteria may apply and will be assessed by the study site","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a TROP2 binder in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.",[26,27,28,29,30],"Metastatic Urothelial Carcinoma","Breast Cancer","TNBC - Triple-Negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","NSCLC",[32,33,27,34,35,36,37,38,39,40,41,42,43],"HR+","HER2-","Non Small Cell Lung Cancer","Triple Negative Breast Cancer","Trop2","TNBC","RayzeBio","Rayze","BMS","Bristol Myers Squibb","RPT","Imaging Agent","NOT_YET_RECRUITING","2026-06-22",{"date":47,"type":48},"2026-06-26","ACTUAL",{"date":50,"type":20},"2026-06",{"date":52,"type":20},"2027-10",{"name":54,"class":55},"RayzeBio, Inc.","INDUSTRY",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":64,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100483291","phase-1-phase-12-study-to-evaluate-ep0062-as-monotherapy-and-in-combination-in-patients-with-advanced-or-metastatic-arher-2-er-breast-cancer-100483291","NCT05573126","Phase 1\u002F2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","A Modular, Open-Label, Multi-Centre Phase 1\u002F2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","Inclusion Criteria:\n\n1. Women 18 years or older at the time of informed consent\n2. Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the American Joint Committee on Cancer\u002FUnion for International Cancer Control\u002FTumour Node Metastases (AJCC\u002FUICC TNM) staging classification (8th Ed, 2017) and where no conventional therapy is available or considered appropriate by the Investigator or is declined by the patient\n3. Availability of archival tumour sample (formalin-fixed, paraffin-embedded block(s) or slides from a primary tumour or biopsy of a metastatic tumour lesion or lesions); in the absence of an archival tumour sample, or if only archival bone tissue is available, a fresh biopsy will need to be collected\n4. Biopsy-proven AR+ and ER+ breast cancer\n\n   * For Module A, AR+ breast cancer is defined as ≥ 10% AR nuclei staining by central immunohistochemistry (IHC) using the Ventana assay\n   * For Modules B and C, AR+ breast cancer is defined as ≥ 30% AR nuclei staining by central IHC using the Ventana assay\n5. HER2-negative breast cancer, defined as negative by fluorescence in situ hybridisation (FISH) or IHC score of 0 or 1+. If IHC is equivocal at 2+, a negative FISH test (HER2\u002FAmplification of the centromeric region of chromosome 17)CEP17 ratio of \\\u003C2.0) is required\n6. Postmenopausal, as defined by at least one of the following:\n\n   1. Age over 60 years\n   2. Amenorrhea \\> 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice)\n   3. FSH and oestradiol in the postmenopausal ranges (as per local practice) in women aged \\\u003C55 years who have undergone hysterectomy\n   4. Prior bilateral oophorectomy\n7. Module B arm 1: patients who have progressed on ≤ 2 prior lines of endocrine therapy, including a prior CDK4\u002F6 inhibitor.\n8. Module B arm 2: patients who have progressed on ≤ 2 prior lines of endocrine therapy in advanced\u002Fmetastatic setting, including prior CDK4\u002F6 inhibitor\n9. Module B arm 3: patients who have progressed on treatment with a prior CDK4\u002F6 inhibitor plus an aromatase inhibitor as initial therapy or recurrence on\u002Fafter treatment with a CDK4\u002F6 inhibitor plus endocrine therapy in the adjuvant setting.\n\nExclusion Criteria:\n\nPatients with any of the following will not be included in the study:\n\n1. Prior anti-cancer or investigational drug treatment within the following time windows:\n\n   * Any chemotherapy within 21 days prior to the first dose of study drug\n   * Any non-chemotherapy investigational anti-cancer drug \\\u003C 5 half-lives (28 days for biologics) or \\\u003C 14 days for small-molecule therapeutics or if half-life is not known\n   * Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug\n   * Fulvestrant or other investigational Selective Estrogen Receptor Degraders (SERDs) within 21 days prior to first dose of study drug\n2. Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens\n3. Radiation therapy within 14 days prior to the first dose of study drug and scheduled to have radiation therapy during participation in this study. Short courses of palliative radiation therapy during the study might be allowed following discussion with and approval by the Medical Monitor. Palliative radiotherapy within 6 weeks prior to first dose of study drug is permitted\n4. Unresolved or unstable serious toxic side effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except fatigue, alopecia, and Grade 2 chemotherapy-induced neuropathy\n5. Confirmed Corrected QT Interval by Fridericia (QTcF) \\> 470 ms on screening ECG, or history of torsades de pointes (TdP), or history of congenital long QT syndrome, or immediate family history of long QT syndrome, unexplained sudden death at a young age, or sudden cardiac death\n6. Any other clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third-degree heart block); rate-controlled atrial fibrillation is permitted\n7. Concomitant medications that prolong the corrected QT interval and\u002For increase the risk for TdP that cannot be discontinued or substituted with another drug within 5 half-lives or 14 days before the first dose of study drug, whichever is longer\n8. Congestive heart failure Grades II-IV according to the New York Heart Association at the time of screening\n9. Myocardial infarction or unstable angina within the previous 6 months\n10. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug\n11. Prior treatment with selected combination agent","FEMALE",{"count":66,"type":20},95,[68,69],"PHASE1","PHASE2","The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer",[72,29,73],"Hormone Receptor-positive Breast Cancer","Metastatic Breast Cancer","RECRUITING","2026-06-17",{"date":45,"type":48},{"date":78,"type":48},"2023-01-11",{"date":80,"type":20},"2028-02",{"name":82,"class":55},"Ellipses Pharma",14,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":103,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":92,"type":20},399,[68],"This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[96,97,73,98,99,100,101,29,102],"Advanced Solid Tumor","Advanced Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Non-small Cell Lung Cancer",[104,105,106,107,108,29,109,110],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer","2026-05-26",{"date":113,"type":48},"2026-05-27",{"date":115,"type":48},"2023-12-01",{"date":117,"type":20},"2028-11",{"name":119,"class":55},"BeOne Medicines",63,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100485990","phase-1-vs-6766abemafulv-in-met-hrher--bc-100485990","NCT05608252","VS-6766+Abema+Fulv in Met HR+\u002FHER- BC","A Single Arm Phase 1\u002F2 Trial of Abemaciclib + Avutometinib (VS-6766) + Fulvestrant in Metastatic HR+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive\u002Fnegative staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.\n* Participants may have measurable or non-measurable disease according to RECIST v1.1.\n* Men and pre- and postmenopausal women are eligible. Ongoing monthly GNRH agonist is required in pre-menopausal women or male participants for at least 4 weeks prior to study entry. If men or pre-menopausal women have not received regular GNRH agonist for at least 4 weeks prior to study entry, these patients will be excluded.\n* Participants must have radiological or objective evidence of progression on any CDK 4\u002F6 inhibitor-containing regimen in the metastatic setting, and\u002For relapse\u002Fprogression during or within 12 months of completion of any CDK4\u002F6 inhibitor-containing regimen in the adjuvant setting.\n\n  * It is not mandatory to have a CDK4\u002F6 inhibitor-containing regimen as the most recent treatment.\n* Participants must have radiological or objective evidence of progression on fulvestrant (as a single agent or as a component of any multi-drug regimen) in the metastatic setting.\n\n  * It is not mandatory to have a fulvestrant-containing regimen as the most recent treatment.\n* Prior therapy:\n\n  * No more than two prior chemotherapy regimens in the metastatic setting.\n  * For both the phase I and phase II portions of this trial, there is no limit on prior lines of endocrine therapy in the adjuvant or metastatic setting.\n* For phase 2 cohort only: Willing to undergo pre- and on-treatment tumor biopsies. Patients are exempt from this requirement if, in the opinion of the investigator, the biopsy procedure would pose a significant risk. Biopsies are optional in the phase 1 cohort.\n* ECOG performance status \\\u003C2.\n* Participants must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥ 1.5 x 109\u002FL\n  * platelets ≥100,000\u002Fμl\n  * hemoglobin ≥9 g\u002FdL (If red blood cell transfusion has been administered, hemoglobin must remain stable and ≥9 g\u002FdL without further transfusion for at least 1 week prior to first dose of study therapy).\n  * total bilirubin ≤1.5mg\u002FdL (≤3.0mg\u002FdL in patients with known Gilbert syndrome and direct bilirubin within normal limits)\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN.\n  * Adequate renal function with a creatinine clearance rate of ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault formula.\n  * International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation.\n  * Creatine phosphokinase (CPK) ≤ 2.5 x ULN.\n  * Adequate cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n  * Baseline QTc interval \\\u003C 480 ms (average of triplicate readings) using Fredericia's QT correction formula. NOTE: This criterion does not apply to patients with a complete or incomplete right or left bundle branch block.\n* Adequate recovery from toxicities related to prior systemic treatments, surgery, or radiotherapy to at least Grade 1 by CTCAE v 5.0. Exceptions include alopecia and peripheral neuropathy grade ≤ 2.\n* Age \\>18 years. Because no dosing or adverse event data are currently available on the use of study agents in participants \\\u003C18 years of age, children are excluded from this study.\n* Women of childbearing potential, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment. Women meeting these criteria will need to use adequate contraception for at least 30 days after the last dose of abemaciclib or VS-6766 and for one year after the last dose of fulvestrant. Men will need to use adequate contraception for 90 days after the last dose of abemaciclib or VS-6766 and for one year after the last dose of fulvestrant. Additionally, males must agree not to donate sperm for the duration of protocol treatment and for at least 90 days after the last dose of protocol therapy. Childbearing potential for this purpose is defined as: those who have not been surgically sterilized and\u002For have had a menstrual period in the past 12 months. Adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and\u002For partner:\n\nHighly Effective Non-Hormonal Contraception Methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly-effective forms of contraception.\n\nThe following non-hormonal methods of contraception are acceptable:\n\n* True abstinence when this is in line with the preferred and usual lifestyle of the participant. \\[Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n* Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner. OR Effective Non-Hormonal Contraception\n\nAlternatively two of the following effective forms of contraception may be used instead:\n\n* Placement of non-hormonal or progesterone-coated intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being used, as there are higher failure rates quoted for certain types, e.g., steel or copper wire.\n* Condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* The use of barrier contraceptives should always be supplemented with the use of spermicide. The following should be noted:\n* Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection.\n* However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.\n\nIt should be noted that two forms of effective contraception are required. A double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n\n* A female of childbearing potential, as defined above in section 3.1.12, must have a negative serum pregnancy test performed within 7 days of C1D1. A positive urine test must be confirmed by a serum test. Pregnancy testing does not need to be pursued in female participants who are:\n\n  * Age \\>60 years; or\n  * Age \\\u003C60 years with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\n  * Status post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Participant must be able to swallow and retain oral medication.\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with active brain metastases or with known carcinomatous meningitis. Stable, treated brain metastases are allowed (this includes participants who have documented radiologic stability at least 4 weeks after radiotherapy, and do not require systemic steroids for management of symptoms from CNS metastatic lesions). Any patients with documented brain metastasis not meeting above criteria for stable treated brain metastasis are considered to have active brain metastases.\n* Phase I: Participants who have discontinued prior abemaciclib for toxicity, at any dose. Phase II: Participants who have discontinued prior abemaciclib for toxicity, if that toxicity occurred at or above the RP2 dose level for abemaciclib that is incorporated into phase II of this trial.\n* Participants who have discontinued prior fulvestrant for toxicity.\n* Prior treatment with any MEK inhibitor.\n* The subject has received another investigational agent within at least 30 days or 5 half-lives of the first dose of study drug, whichever is longer, or is currently enrolled in any medical device research or other research that is judged by the sponsor to not be scientifically or medically compatible with this study.\n* The subject has received a chemotherapy agent or immunotherapy within 21 days of the first dose of study drug.\n* The subject has received an endocrine or biologic agent within 14 days of the first dose of study drug.\n* The subject has completed radiation within 14 days of registration. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy.\n* The subject has had major surgery within 14 days of registration.\n* Participants with the following pre-existing ocular pathology are excluded:\n* Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes.\n* Patient with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n* Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions.\n* History of rhabdomyolysis or neuromuscular disorders that are associated with elevated CK (eg inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* The patient has an uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure (New York Heart Association Class III or IV), active ischemic heart disease, myocardial infarction within the previous six months, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), uncontrolled diabetes mellitus, severe obstructive pulmonary disease, or severe chronic liver or renal disease, or sudden cardiac arrest.\n* Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are potentially eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years and there is no evidence of disease recurrence for 1 year or more since completion of appropriate therapy: cervical cancer in situ, and non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the overall study PI to determine eligibility.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to VS-6766 (including inactive ingredients mannitol, magnesium stearate, HPMC (hydroxypropylmethylcellulose) shells), abemaciclib, or fulvestrant.\n* Known history of testing positive for HIV with history of an AIDS-defining opportunistic infection within the past 12 months, or need to receive combination antiretroviral therapy for HIV that are strong CYP3A4 inhibitors or inducers.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (for example, hepatitis B surface antigen positive). Screening is not required for enrollment. Patients with chronic HBV infection who meet criteria for anti-HBV therapy should be on suppressive antiviral therapy prior to initiation of study therapy. Patients with a history of HCV infection will need to have completed curative antiviral treatment with HCV viral load below the limit of quantification. Patients with untreated HCV may be enrolled if the HCV is stable and if the patient is not at risk for hepatic decompensation. Patients that need to receive antiviral therapy for HBV or HCV that are strong CYP3A4 inhibitors or inducers will be excluded.\n* Patients exposed to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study drugs (see Appendix C). Concurrent use of strong CYP3A4 inhibitors (see Appendix C), such as ketoconazole and erythromycin, or inducers (see Appendix C), such as St. John's wort, should be avoided during the study treatment.\n* Pregnant women are excluded from this study because effect of combination VS-766, abemaciclib, and fulvestrant on a developing fetus is unknown. Breastfeeding should be discontinued prior to entry onto the study.\n* Patients with the inability to swallow oral medications, impaired gastrointestinal absorption due to gastrectomy or other major surgical resection involving the stomach or small bowel, preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea, or other medical issue that would impact absorption of oral medication in the opinion of the investigator.\n* Patients with active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), or fungal infection (requiring IV antifungal treatment at time of initiating study treatment), or severe acute respiratory syndrome from coronavirus 2 (SARS-Cov2) infection ≤28 days prior to first dose of study treatment.\n* Patients on treatment with warfarin. Individuals on treatment with warfarin must be transitioned to anticoagulation instead with low-molecular-weight heparin or a direct oral anticoagulant prior to first dose of study treatment.\n* Any other serious and\u002For uncontrolled preexisting medical condition(s) (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, other cardiac, gastrointestinal, pulmonary, psychiatric, neurological, or genetic conditions, etc.) that in the opinion of the Investigator would place the patient at unacceptably high risk for toxicity and therefore preclude participation in this study.",{"count":120,"type":20},[68,69],"This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+\u002FHER2-negative breast cancer.\n\nThe names of the study drugs involved in this study are:\n\n* VS-6766\n* Abemaciclib\n* Fulvestrant",[27,72,29],[27,72,29],"2026-04-27",{"date":135,"type":48},"2026-04-30",{"date":137,"type":48},"2023-02-23",{"date":139,"type":20},"2028-12-31",{"name":141,"class":142},"Adrienne G. Waks","OTHER",3,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100628292","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-hlx43-in-patients-with-hormone-receptor-positive-her2-negative-locally-advanced-or-metastatic-breast-cancer-100628292","NCT07459738","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Male\u002Ffemale who are at least 18 years of age and and no more than 75 years old on the day of signing the informed consent.\n2. With histologically confirmed diagnosis of HER2-negative, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.\n3. Must have experienced disease progression after receiving at least one line of endocrine therapy for advanced or metastatic disease.\n4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.\n5. ECOG PS: 0-1.\n6. Expected survival ≥ 6 months.\n7. Had adequate organ function\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors within 3 years before the randomization\n2. Prior documented interstitial lung disease (ILD)\u002F pneumonitis that required steroids, current ILD\u002F pneumonitis, or suspected ILD\u002Fpneumonitis\n3. Lung-specific intercurrent clinically significant illnesses\n4. Uncontrolled or significant cardiovascular disease or infection\n5. Prior adverse events leading to permanent discontinuation of immunotherapy; or prior immune-related pneumonia or immune-related myocarditis of grade ≥2.","75 Years",{"count":153,"type":20},60,[69],"This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first)",[29],[158,159,27],"HLX43","anti-PD-L1 ADC","2026-03-05",{"date":162,"type":48},"2026-03-10",{"date":164,"type":20},"2026-04-01",{"date":166,"type":20},"2027-12-30",{"name":168,"class":55},"Shanghai Henlius Biotech",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":64,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":56},"100506740","impact-of-endocrine-therapy-menstrual-cycle-pam50-ki67-on-treatment-decisions-in-hr-and-her2--breast-cancer-100506740","NCT05878314","Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer","Impact of Preoperative Endocrine Therapy, Menstrual Cycle, PAM50 Assessment and Ki67 Dynamics on Adjuvant Treatment Decisions in Hormone Receptor-positive and HER2-negative Patients With Early Breast Cancer","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven unilateral primary non-metastatic invasive breast cancer\n* Estrogen receptor (ER)-\u002F or Progesterone receptor (PR)- positive and HER2-negative\n* Ki67 from core biopsy is available\n* no lymph-node involvement by clinical evaluation and ultrasound (cN0)\n* not amendable to neoadjuvant chemotherapy\n* surgery or planned surgery at the Department for Women's Health, Tuebingen or Freiburg\n* planned preoperative endocrine treatment with Tamoxifen, Aromatase inhibitors, Goserelin or nothing for 2 - 4 weeks\n* written informed consent\n\nExclusion Criteria:\n\n* ER-negative and PR-negative\n* HER2-positive\n* bilateral breast cancer\n* preexisting cancer disease within the last 10 years\n* preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria)\n* any systemic breast cancer therapy before inclusion into the trial\n* indication for neoadjuvant chemotherapy\n* any systemic therapy except Tamoxifen, Aromatase inhibitors, Goserelin before surgery\n* locally advanced, inoperable or metastatic breast cancer\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)\n* hormonal contraception within 6 months before inclusion",{"count":177,"type":20},504,"OBSERVATIONAL","PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors ± gonadotropin-releasing hormone (GnRH)-Analogues or nothing or no preoperative endocrine treatment as part of the clinical routine. The investigators moreover address the question whether PAM50 assessment in addition to Ki67 dynamics still impacts treatment recommendations.",[29],"2026-02-09",{"date":183,"type":48},"2026-02-10",{"date":185,"type":48},"2023-04-25",{"date":187,"type":20},"2035-04",{"name":189,"class":142},"University Hospital Tuebingen",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":213,"locationsCount":215},"100544469","phase-2-a-study-of-alisertib-in-combination-with-endocrine-therapy-in-patients-with-hr-positive-her2-negative-recurrent-or-metastatic-breast-cancer-100544469","NCT06369285","A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer","ALISCA-Breast1","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy.\n* Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.\n* Participants must have received a CDK4\u002F6i in combination with endocrine therapy in the recurrent or metastatic setting.\n* HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) or European Society of Medical Oncology (ESMO) guidelines:\n\nExclusion Criteria:\n\n* Treatment with chemotherapy in the recurrent or metastatic setting.\n* Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.\n\nNote: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.",{"count":199,"type":20},150,[69],"PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive\u002FHER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.",[29,73,203],"Recurrent Breast Cancer",[205,206,203,73],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor 2 negative (HER2-)","2025-12-03",{"date":209,"type":48},"2025-12-10",{"date":211,"type":48},"2024-11-19",{"date":139,"type":20},{"name":214,"class":55},"Puma Biotechnology, Inc.",53,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":226,"briefSummary":227,"conditions":228,"keywords":232,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":246},"100531548","phase-2-evaluating-the-addition-of-elacestrant-oral-serd-to-olaparib-parp-inhibitor-in-patients-with-advancedmetastatic-hrher2--breast-cancer-100531548","NCT06201234","Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced\u002FMetastatic HR+\u002FHER2- Breast Cancer","Phase II Study Evaluating the Addition of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD), to Standard-of-care Olaparib in Patients With Hormone Receptor (HR)-Positive, HER2-negative Locally Advanced or Metastatic Breast Cancer With gBRCA1\u002F2 Mutations","ELEMENT","Inclusion Criteria:\n\nPatients will be eligible for study participation only if they comply with the following criteria:\n\n1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for scheduled visit, the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.\n2. Female or male patients.\n3. Age at study entry of at least 18 years.\n4. Locally advanced or metastatic breast cancer that is HR-positive (ER and\u002For PgR ≥ 10% of stained cells at IHC) and HER2-negative (IHC 0 or 1+, or 2+ and ISH negative according to ASCO\u002FCAP guidelines).\n5. Patients with deleterious or suspected deleterious gBRCA1\u002F2 mutation detected upon local testing.\n6. Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block or a partial block from archived tumor or metastasis.\n7. Indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.\n9. Resolution of all acute toxic effects of prior anti-cancer therapy including endocrine therapy or surgical procedures to NCI CTCAE version 5.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n10. Life-expectancy \\> 6 months.\n11. For female patients: patients of childbearing potential (defined as not post-menopausal and not permanently sterile \\[latter defined as having undergone hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\\]) require a negative serum or urinary pregnancy test within 72 hours before starting treatment in this study (in this case, patients need to use highly effective non-hormonal contraceptive methods as specified in the protocol).\n\nFor male patients: during the intervention period and for at least 120 days after the last dose of elacestrant, patients should refrain from heterosexual intercourse or use a condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak), and they should refrain from donating sperm.\n\nExclusion Criteria:\n\nPatients will be ineligible for study participation if they fulfill any of the following criteria:\n\n1. Known hypersensitivity reaction to one of the compounds, excipients, or substances used in this protocol.\n2. Active or newly diagnosed CNS metastases, including leptomeningeal carcinomatosis, carcinomatous meningitis, or radiographic signs of CNS hemorrhage. Note: Patients with stable brain metastases are allowed. Radiotherapeutic treatment must be completed 1 week before planned day 1 of study therapy.\n3. Presence of symptomatic metastatic visceral disease that are at risk of life-threatening complications in the short term, including but not confined to massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or fulminant liver involvement.\n4. Inadequate organ function prior to enrolment including:\n\n   * Hemoglobin \\\u003C 9 g\u002FdL (\\\u003C 5.6 mmol\u002FL)\n   * Absolute neutrophil count (ANC) \\\u003C 1500\u002Fmm³ (\\\u003C 1.5 x 109\u002FL)\n   * Platelets \\\u003C 100,000\u002Fmm³ (\\\u003C 100 x 109\u002FL)\n   * Alanine aminotransferase (ALT\u002FSGPT) and\u002For aspartate aminotransferase (AST\u002FSGOT) \\> 3 x upper normal limits (ULN). If the patient has liver metastases, ALT and AST should not be ≥ 5 x ULN.\n   * Alkaline phosphatase (ALP) \\> 2.5 x ULN\n   * Total serum bilirubin \\> 1.5 x ULN (exception: patients with Gilbert's syndrome permitted up to ≤ 3 x ULN)\n   * Serum creatinine \\> 1.5 x ULN or estimated creatinine clearance \\\u003C 50 mL\u002Fmin as calculated using the standard method for the institution.\n5. Existing contraindication against the use of the elacestrant or olaparib.\n6. Prior treatment with PARP inhibitors.\n7. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and for a predefined period after the end of treatment (as described in protocol).\n\n   Male patients: intention to get a child during the study and for a predefined period after the end of treatment (as described in protocol).\n\n   According to the treatment received during the study, required contraception timelines for female and male patients are described in the study protocol.\n8. Any of the following within 6 months prior to enrolment: myocardial infarction, severe\u002Funstable angina, ongoing grade ≥ 2 cardiac dysrhythmias, prolonged QT corrected by Fridericia's formula (QTcF) grade ≥ 2, uncontrolled atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, heart failure of New York Heart Association (NYHA) Class II or greater, or cerebrovascular accident including transient ischemic attack.\n9. Uncontrolled hypertension at the time of screening (systolic BP \\> 140 mmHg or diastolic BP \\> 90 mmHg that has not been adequately treated or controlled).\n10. Active and current anticoagulation for treatment purposes of thrombotic events occurring \\\u003C 6 months before enrolment is not allowed (prophylactic anticoagulation, however, is acceptable). Treatment with an anticoagulant for a thrombotic event occurring \\> 6 months before enrolment, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation) is acceptable, provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to the first dose of study drug.\n11. Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass.\n12. History of endometrial intraepithelial neoplasia in patients who have not undergone a hysterectomy.\n13. Malignant disease other than breast cancer, active or being disease-free for less than 5 years (except carcinoma in situ of the cervix, DCIS, and non-melanomatous skin cancer adequately treated).\n14. Uncontrolled significant active infections including HBV, HCV, and\u002For HIV. Patients with a positive hepatitis B surface antigen result or a positive hepatitis C antibody test result at screening or within 3 months before first dose of study treatment are excluded, except for the following:\n\n    * Participants with positive anti-HBs antibody titer and confirmatory negative hepatitis B DNA polymerase chain reaction.\n    * Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if they have both completed curative therapy and have a hepatitis C viral load \\\u003C quantifiable limit.\n15. Any severe, acute, uncontrolled, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational or non-investigational products administration, or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Moreover, patients who, by virtue of an order issued by judicial or administrative authorities, are committed to an institution or those who cannot take part in clinical trials are excluded from this study.\n16. History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent.\n17. Unable or unwilling to avoid medications, supplements (e.g., St. John's wort), or foods (e.g., grapefruit, pomegranate, pomelos, star fruit, Seville oranges and their juices) that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, or foods are discontinued for at least 14 days prior to study entry and for the duration of the study.\n18. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.\n19. Receipt of live attenuated vaccination within 30 days prior to study entry. COVID-19 vaccines that do not contain live viruses are allowed (at least one week prior to study entry).",{"count":225,"type":20},176,[69],"Trial design:\n\nPhase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1\u002F2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.\n\nTrial population:\n\nPatients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1\u002F2 mutation, with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib, an ECOG performance status of 0-2 and life expectancy of \\> 6 months, with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system (CNS) metastases or symptomatic metastatic visceral disease at risk of life-threatening complications.\n\nInterventions:\n\nPatients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily, while patients randomized to Arm B will receive 600 mg olaparib daily. Blood tests (hematology, biochemistry) will be performed at the beginning of every cycle, and imaging for tumor assessment (chest and abdominopelvic imaging) as well as QoL assessments will be performed every three months and in case of suspicion of progression\u002Fend of study.",[29,229,230,231],"Advanced or Metastatic Breast Cancer","BRCA1 Mutation","BRCA2 Mutation",[233,234,235,236,237],"Elacestrant","Olaparib","Breast cancer","Metastases","Palliative therapy","2025-11-24",{"date":240,"type":48},"2025-12-01",{"date":242,"type":48},"2024-12-13",{"date":139,"type":20},{"name":245,"class":142},"GBG Forschungs GmbH",36,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":257,"conditions":258,"keywords":296,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":256,"type":20},3500,"PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[259,260,261,262,263,264,265,27,266,267,268,269,270,271,272,273,274,275,276,277,278,99,279,29,100,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Carcinoma","Breast Diseases","Breast Neoplasms","Breast Neoplasms, Male","Breast Cancer With Metastatic Bone Disease","Breast Cancers","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[297,298,291,292,293,299,300,73],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","2025-01-28",{"date":303,"type":48},"2025-02-03",{"date":305,"type":48},"2023-05-01",{"date":307,"type":20},"2040-12-31",{"name":309,"class":142},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24,{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":64,"minAge":17,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":21,"phases":321,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":56},"100508515","phase-3-tcb-vs-ec-t-in-high-risk-erher2--breast-cancer-100508515","NCT05901428","TCb vs EC-T in High Risk ER+\u002FHER2- Breast Cancer","A Randomized, Open-label, Single-center, Phase III Trial Comparing Docetaxel Plus Carboplatin (TCb) Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel (EC-T) Regimen as Adjuvant Chemotherapy in Patients With LN≥4 Estrogen Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative (ER+\u002FHER2-) Breast Cancer","Inclusion Criteria:\n\n1. Women aged 18-70\n2. Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)\n3. The initial diagnosis condition can be directly operated, without absolute surgical contraindications\n4. No gross or microscopic tumor remains after surgical resection\n5. Adjuvant chemotherapy should be started within eight weeks after surgery\n6. Patients with Hormone receptor-positive, HER2-negative (HR+HER2-), and positive axillary lymph nodes ≥4\n7. Definition of ER and Progesterone Receptor (PgR) positive: Positive ER for tumor cells detected by immunohistochemistry is defined as ER positive , and positive PgR for tumor cells detected as PgR positive .\n8. There was no evidence of metastasis in clinical or imaging aspects during preoperative examination\n9. No peripheral neuropathy;\n10. Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1\n11. Good postoperative recovery, at least 1 week interval between surgery\n12. Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells\u002FμL (no granulocyte colony stimulating factor (G-CSF) support therapy within 2 weeks prior to day 1 of course 1); Lymphocyte count≥ 500 cells\u002FμL; Platelet count≥ 100,000 cells\u002FμL (no platelet transfusion within 2 weeks before day 1 of course 1; hemoglobin≥ 9.0 g\u002FdL; Aspartate transferase (AST), Alanine aminotransferase (ALT), and alkaline phosphatase≤ 2.5 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; Patients with known Gilbert disease and serum bilirubin levels ≤ 3× ULN may be admitted; For patients not receiving anticoagulant therapy: INR or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN within 28 days prior to initiation of study therapy; For patients receiving anticoagulant therapy: a stable anticoagulant regimen within 28 days before the start of study therapy and a stable International normalised ratio (INR); creatinine clearance≥ 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula); Serum albumin ≥ 2.5 g\u002FdL\n13. For women of childbearing age: agree to remain abstinent (avoid heterosexual intercourse) or take an annual failure rate for at least 5 months during treatment and at least 6 months after the last dose of docetaxel or epirubicin, or 12 months after the last dose of cyclophosphamide, whichever occurs last \\\u003C 1% of contraception. A woman who is postmenopausal but has not yet reached postmenopausal status (menopause lasts ≥for 12 consecutive months, for no reason other than menopause) and has not undergone sterilization (ovarian and\u002For hysterectomy) is considered fertile.\n14. Cardiac function: left ventricular ejection fraction (LVEF) \\>50% by ultrasound examination\n15. Sign the Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n1. Have a history of invasive cancer\n2. T4 clinical tumors as specified in the Union for International Cancer Control\u002FAmerican Joint Committee on Cancer tumor (UICC\u002FAJCC) Tumor-Lymph Node Metastasis Classification (8th Edition), including inflammatory breast cancer\n3. For currently diagnosed breast cancer, prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib, neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer radiotherapy (RT), except for treatments planned under this study condition\n4. Previous treatment with anthracyclines or taxane for any malignant tumor\n5. History of ductal carcinoma in situ (DCIS) and\u002For lobular carcinoma in situ (LCIS), treatment of ipsilateral breast cancer with systemic therapy, hormone therapy, or RT, followed by invasive cancer, patients treated with DCIS\u002FLCIS only surgery and\u002For RT for contralateral DCIS may be enrolled in the study.\n6. Prior to randomization, cardiopulmonary dysfunction according to any of the following: history of NCI CTCAE v4.0 ≥3 symptomatic congestive heart failure or New York College of Cardiology (NYHA) standard classification≥ II, angina requiring antianginal drugs, severe arrhythmias not treated with appropriate medical therapy, severe conduction abnormalities, or clinically significant valvular disease, high-risk, uncontrolled arrhythmias (i.e., atrial tachycardia with \\> resting rate). 100\u002Fmin, significant ventricular arrhythmia \\[ventricular tachycardia\\], or high-grade atrioventricular (AV) block \\[second-degree AV block type 2, or third-degree atrioventricular block\\]), significant symptoms associated with left ventricular dysfunction, arrhythmia, or myocardial ischemia (grade ≥2), myocardial infarction within 12 hours prior to randomization; with uncontrolled hypertension (systolic blood pressure\\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg; ECG findings show transmural infarction; Oxygen therapy is required\n7. Prior malignancy within 5 years prior to randomization, with negligible risk of metastasis or death, except for malignancy that is expected to heal after treatment (i.e., appropriately treated carcinoma in situ or basal or squamous cell skin cancer).\n8. Known allergic or hypersensitivity to any component of the docetaxel, carboplatin, cyclophosphamide, or epirubicin preparations; Allergic or hypersensitivity reactions are known to filgrastim, pegfilgrastim, or granulocyte-macrophage colony-stimulating factor (GM-CSF) preparations\n9. Patients with serious infections (including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia) that occurred within 4 weeks prior to initiation of study treatment, who received therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment, and who received prophylactic antibiotic therapy (such as prophylaxis for urinary tract infection or prevention of chronic obstructive pulmonary disease) may be enrolled.\n10. Pregnant or lactating women, or women planning to become pregnant during the study period.\n11. Poorly controlled hypertension (defined as: systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\>100 mmHg)\n12. Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, and inability to complete the trial protocol and follow-up workers (systematic evaluation is required before trial enrollment)\n13. Persons without personal freedom and independent capacity for civil conduct.","70 Years",{"count":320,"type":20},1736,[322],"PHASE3","This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+\u002FHER2-) breast cancer.",[29],[326,327,328],"LN≥4","TCb","EC-T","2023-06-12",{"date":331,"type":48},"2023-06-15",{"date":333,"type":48},"2023-06-01",{"date":335,"type":20},"2028-06",{"name":337,"class":142},"Fudan University"]